Catalog Number Z497E |
Device Problems
Break (1069); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What do you mean by "defect led to disunities of wound scar? please explain.Did the suture break intra-op? did the suture knots untie intra-op? any patient consequence/ae outcome as a result of the event report?.
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Event Description
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It was reported that patient underwent an unknown visceral surgery on (b)(6) 2019 and suture was used.The strand is white and opaque instead of being transparent as usual.The strands are thicker, more rigid and more brittle than usual.Use of another device from different lot to complete the procedure.The patient may have had disunity of wound scar.No treatment was reported.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 2/27/2020.A manufacturing record evaluation was performed for the finished device mdm411 batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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